Complications of Perfusion Clinical Trial
Official title:
Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study
Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in
real-time during surgery. Complications due to vascular compromise are a major problem,
especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue
necrosis. If, however, perfusion and ischemia could be monitored during surgery, then
surgeons could change their reconstructive design and the anaesthesiologists could improve
perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a
tool that is able to image in high resolution (microvascularisation), direct,
intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying
vessels) and that produces quantitative data to objectify image interpretation.
Optical techniques, based on the interaction of light with tissue, are able to image tissue
at high resolution and in real-time. These techniques are FDA-approved and have emerged as
powerful diagnostic tools in different departments of medicine, such as ophthalmology for
visualizing retina vascularisation and dermatology for skin diagnostics.
In this study, investigators hypothesize that four novel optical technologies: Fluorescence
Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream
Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.
Primary objective - Perfusion will be measured with all the techniques focussed on 4 areas;
from 'good' to 'decreased' perfusion (biologically)
Fluorescence Imaging (FI): Time to intensity measurements at four sides Laser Speckle
Contrast Imaging (LSCI): Perfusion Units Optical Coherence Tomography (OCT): Vessel density &
decorrelation time Sidestream Darkfield Microscopy (SDF): Total vessel density, proportion of
perfused vessels, perfused vessel density, max flow index, De Backer score, perfusion in
mm/sec.
Differences in parameters between the four sites will be statistically be compared.
Secondary objectives
- Relation of parameters to patient outcome in terms of adverse events.
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